Motivational Interviewing and Guided Opioid Tapering Support to Promote Postoperative Opioid Cessation

December 16, 2023 updated by: Jennifer Hah, Stanford University

Randomized Controlled Trial to Evaluate the Relative Efficacy of Motivational Interviewing and Guided Opioid Tapering Support vs. Enhanced Usual Care to Promote Opioid Cessation After Orthopedic Surgery

The purpose of this study is to evaluate the relative efficacy of enhanced usual care versus motivational interviewing and guided opioid tapering support to promote opioid cessation after total hip or knee replacement surgery.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Planning to undergo surgery
  • English speaking
  • Ability and willingness to complete questionnaires and assessments
  • Scheduled for total hip, knee, or shoulder replacement
  • Preoperative opioid use and opioid use 14 days after surgery to increase the likelihood of delayed opioid cessation.
  • Not under the care of a current pain management provider

Exclusion Criteria:

  • Any conditions causing inability to complete assessments
  • Known pregnancy
  • Elevated suicidality
  • Enrollment in conflicting perioperative trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Motivational Interviewing and Guided Opioid Tapering Support
Behavioral: Motivational Interviewing and Guided Opioid Tapering Support
Following surgery, participants will undergo motivational interviewing with a trained member of the study staff. These calls will occur weekly for 6 weeks with a follow-up call at 10 weeks or until the participant completes the protocol.
Experimental: Enhanced Usual Care
Behavioral: Enhanced Usual Care
Following surgery, participants will receive phone calls from a trained member of the study staff to discuss various aspects of surgical recovery and medication use. These calls will occur weekly for 6 weeks with a follow-up call at 10 weeks or until the participant completes the protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Opioid Cessation
Time Frame: Through study completion, an average of 1 year
Time to opioid cessation between the two groups will be analyzed using survival analysis
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid Misuse
Time Frame: Through study completion, an average of 1 year
Participant score on the Current Opioid Misuse Measure and prescription information obtained via CURES 2.0 will be used to assess opioid misuse behaviors.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Jennifer Hah, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2019

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

April 10, 2018

First Submitted That Met QC Criteria

September 4, 2018

First Posted (Actual)

September 6, 2018

Study Record Updates

Last Update Posted (Actual)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 16, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-43163
  • 1R01DA045027-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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